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タイトル: Palbociclib in combination with letrozole as first-line treatment for advanced breast cancer: A Japanese phase II study
著者: Masuda, Norikazu
Nishimura, Reiki
Takahashi, Masato
Inoue, Kenichi
Ohno, Shinji
Iwata, Hiroji
Mori, Yuko
Hashigaki, Satoshi
Muramatsu, Yasuaki
Nagasawa, Takashi
Umeyama, Yoshiko
Toi, Masakazu  KAKEN_id  orcid https://orcid.org/0000-0003-1488-9958 (unconfirmed)
キーワード: advanced breast cancer
cyclin-dependent kinase
Japanese
letrozole
palbociclib
発行日: 3-Mar-2018
出版者: Wiley-Blackwell
誌名: Cancer Science
巻: 109
号: 3
開始ページ: 803
終了ページ: 813
抄録: This single‐arm, open‐label, phase II study in 42 Japanese postmenopausal patients with estrogen receptor‐positive/human epidermal growth factor receptor 2‐negative (ER+/HER2−) advanced breast cancer evaluated the efficacy, safety, and pharmacokinetics of first‐line palbociclib (125 mg once daily, 3 weeks on/1 week off) coadministered with letrozole (2.5 mg once daily). Primary endpoint of investigator‐assessed 1‐year progression‐free survival (PFS) probability was 75.0% (90% CI, 61.3%‐84.4%), far surpassing the 40% lower limit of the 90% CI supporting efficacy. Median duration of treatment was 438 days. Among secondary efficacy measures, median PFS was not reached (95% CI, 16.7: not estimable), 17/42 patients (40.5%) had an objective response, 36/42 (85.7%) maintained disease control, and 27/42 (64.3%) remained in follow‐up. Median overall survival was not reached, and 1‐year survival probability was 92.9% (95% CI, 79.5%‐97.6%). Results of intensive pharmacokinetics in a subset of 6 patients showed palbociclib steady‐state mean area under the plasma concentration‐time curve over the dosing interval [τ] and mean maximum plasma concentration were 1979 ng·h/mL and 124.7 ng/mL, respectively. For day 15 plasma samples from cycles 1 and 2, geometric mean of the within‐patient mean trough concentration was 90.1 ng/mL. The most common treatment‐related adverse events were neutropenia (100%) and stomatitis (73.8%). There was 1 case of treatment‐related febrile neutropenia. Toxicities were generally tolerated and manageable by dose modifications and/or medical care. Efficacy and safety of first‐line palbociclib plus letrozole therapy is supported in Japanese postmenopausal patients with treatment‐naive ER+/HER2− advanced breast cancer.
著作権等: © 2018 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
URI: http://hdl.handle.net/2433/230440
DOI(出版社版): 10.1111/cas.13507
PubMed ID: 29345736
出現コレクション:学術雑誌掲載論文等

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